Update on Idelalisib (Zydelig)

At Gilead, patient safety is our highest priority and we continuously monitor safety information about our medicines to inform their appropriate use. A review of ongoing Zydelig (idelalisib) Phase 3 studies found an increased risk of serious adverse events and death, generally due to infections, in patients receiving Zydelig for first-line treatment of chronic lymphocytic leukemia (CLL) and relapsed indolent NHL (iNHL).

As a result of this new information, we are proactively terminating several ongoing studies in first line CLL and iNHL and relapsed iNHL and conducting a comprehensive review of all ongoing studies. Gilead believes that Zydelig is an important treatment option for relapsed CLL and refractory follicular lymphoma and small lymphocytic lymphoma patients who generally have limited effective therapeutic options, and we are consulting with regulatory authorities on next steps.